Shionogi & Co., Ltd. · TSE:4507
Shionogi & — H1 FY2025 Earnings Presentation
52 slides from Shionogi &'s earnings presentation, Oct 27, 2025
Slide 1: 1st Half (Interim period) of Fiscal 2025 Financial Results
1st Half (Interim period) of Fiscal 2025 Financial Results October 27, 2025 Shionogi & Co., Ltd. 1
Slide 2: Agenda
Agenda 1. Overview of 1st Half (Interim period) FY2025 01 （P.3-10） 2. FY2025 Financial Forecasts 02 （P.11-16） 3. Domestic and Overseas Business Outlook 03 （P.17-24） 4. Toward the Realization of the 2030 Vision 04 （P.25-36） 5. Shareholder Return （P.37-38） 05 2
Slide 3: Overview of 1st Half (Interim period) FY2025 Financial Results
Overview of 1st Half (Interim period) FY2025 Financial Results 3
Slide 4: 1st Half FY2025 Highlights
1st Half FY2025 Highlights Maintain revenue and operating profit at the same level as the previous year − Stable profit growth in the HIV business and overseas businesses Profit before tax increased, and profit attributable to owners of parent increased slightly − Increased dividend from ViiV re
Slide 5: Financial Results
Financial Results Revenue and operating profit declined year-on-year, but profit before tax and profit attributable to owners of parent exceeded the previous year (Unit: B yen) FY2025 FY2024 Y on Y Forecasts Achievement 1H results 1H results Change (%) Change Full year 1H (%) Revenue 530.0 233.0 213
Slide 6: Statement of Profit or Loss
Statement of Profit or Loss (Unit: B yen) FY2025 FY2024 Y on Y Forecast Achievement Full year 1H 1H Results (%) 1H Results Change (%) Change Main variation factors (Y on Y) Revenue 530.0 233.0 213.0 91.4 214.0 (0.5) (1.0) Revenue 16.6 14.2 13.7 14.1 Cost of Sales • Increase: Royalty income, Overseas
Slide 7: Analysis of Operating Profit Factors (vs. 1H forecast)
Analysis of Operating Profit Factors (vs. 1H forecast) Thorough cost management based on the epidemic situation reduces discrepancies with forecasts Implemented thorough cost (Unit: B yen) (7.2) optimization across all divisions 820 82.0 • SG&A 56 5.6 748 74.8 37 3.7 △2 - Refined decision-making thr
Slide 8: Revenue by Segment
Revenue by Segment (Unit: B yen) FY2025 FY2024 Y on Y Forecast Achievement Main variation factors (Y on Y) 1H Results 1H Results Change(%) Change Full year 1H (%) Prescription drugs 183.0 62.0 36.8 59.4 47.7 (22.8) (10.9) Prescription drugs Overseas subsidiaries/export 54.9 25.7 30.6 119.2 28.3 8.1
Slide 9: Prescription Drugs in Japan
Prescription Drugs in Japan （Unit: B yen) FY2025 FY2024 Y on Y Forecast Forecast Achievement 1H 1H Results Change(%) Change Full year 1H (%) Results Acute Respiratory Virus Infection 85.8 31.0 8.7 28.0 24.9 (65.1) (16.2) Treatments Quviviq 9.3 1.2 0.4 35.6 - ‐ 0.4 Symproic 8.1 3.9 2.9 75.0 2.4 23.9
Slide 10: Results for the 1H of FY 2025 and Future Outlook
Results for the 1H of FY 2025 and Future Outlook Accelerate efforts toward sustainable growth based on 1H results and challenges 1H results Challenges Solid progress in the HIV business and Growth in domestic business overseas businesses • Stabilization of acute respiratory infection Revenue • Good
Slide 11: FY2025 Financial Forecasts
FY2025 Financial Forecasts 11
Slide 12: Revision of Earnings Forecast
Revision of Earnings Forecast Revenue and all profit items are expected to increase compared to the previous year (Unit: B yen) FY2025 FY2024 Y on Y Initial Revised Revised Result Change (%) Change Forecast Forecast Amount Revenue 530.0 500.0 (30.0) 438.3 14.1 61.7 Operating profit 175.0 185.0 10.0
Slide 13: Assumptions Underlying the Revised Forecast
Assumptions Underlying the Revised Forecast Revenue forecast revised downward, while all profit metrics revised upward ー Topline ー ー Cost management ー Upward Royalty income and SG&A revision overseas subsidiaries/exports • A zero-based review following the shortfall first-half revenue • Increase in
Slide 14: Consolidated Statement of Income
Consolidated Statement of Income （Unit: B yen） FY2025 Forecast Full year FY2025 Forecast 2H FY2024 Y on Y Initial Revised Revised Forecast Revised Revised Result Change(%) Change Forecast Forecast Amount (May. 12) Forecast Amount Revenue 530.0 500.0 (30.0) 297.0 287.0 (10.0) 438.3 14.1 61.7 16.6 16.
Slide 15: Revenue by Business Segment
Revenue by Business Segment （Unit: B yen） FY2025 Forecast Full year FY2025 Forecast 2H FY2024 Y on Y Initial Revised Revised Forecast Revised Revised Result Change(%) Change Forecast Forecast Amount (May 12) Forecast Amount Prescription drugs 183.0 143.5 (39.5) 121.0 106.7 (14.3) 98.8 45.3 44.7 Over
Slide 16: Domestic Prescription Drug Revenue
Domestic Prescription Drug Revenue （Unit: B yen） FY2025 Forecast Full year FY2025 Forecast 2H FY2024 Y on Y Initial Revised Revised Forecast Revised Revised Result Change(%) Change Forecast Forecast Amount (May 12) Forecast Amount Acute Respiratory Virus Infection 85.8 56.0 (29.8) 54.8 47.3 (7.5) 51
Slide 17: Domestic and Overseas Business Outlook
Domestic and Overseas Business Outlook 17
Slide 18: Strategic Directions for Infectious Diseases area
Strategic Directions for Infectious Diseases area Ensuring social contribution and revenue stability through a diversified portfolio of infectious disease treatments - COVID-19 treatment - - Influenza treatments - XOCOVA XOFLUZA RAPIACTA (3CL protease inhibitor) (Cap-dependent endonuclease inhibitor
Slide 19: Review of our Efforts against COVID-19
Review of our Efforts against COVID-19 Modest overall treatment rate growth, significant increase among High-Risk*1 patients ーTreatment rate and Xocova share among oral antiviralsー ーTreatment rate by risk categoryー HR patients 29.4 %* 7.1% FY2025 Target FY2024 1H FY2025 1H 3( up Y on Y) Average Appr
Slide 20: Future Initiatives for COVID-19
Future Initiatives for COVID-19 Strengthening activities to prevent severe disease in HR patients requiring early diagnosis and treatment ーNeed for Preventing Severe Disease in HR Patientsー ーEnhancing Xocova Information Provision Activitiesー The current treatment rate is insufficient, and the Streng
Slide 21: Strategic Directions for QOL Diseases area
Strategic Directions for QOL Diseases area Making QOL disease area a business pillar alongside infectious diseases area Drive substantial growth Torii in the QOL diseases area Broad product portfolio delivering steady growth • Allergen immunotherapy: Cedacure etc Torii • Dermatology: Corectim / Vtam
Slide 22: Driving Growth of Quviviq (Insomnia treatment)
Driving Growth of Quviviq (Insomnia treatment) Market penetration accelerated with the lifting of prescription period restrictions on December 1st. Insomnia Market*1 Current Status Market size: Estimated at over ¥100 billion annually • Limited prescription duration: Maximum of - Growth of DORAs*2 dr
Slide 23: Strengthening QOL Disease Area by Full Acquisition of Torii Pharmaceutical
Strengthening QOL Disease Area by Full Acquisition of Torii Pharmaceutical Achieving stable growth in both the allergen and dermatology segments Allergens Dermatology Sales Trend of SLIT Formulations*1 180 Sales Trend 250 （Forecast） 160 200 140 Revenue（B yen） 120 Revenue (B yen) 150 100 Corectim コレク
Slide 24: Further Growth of Overseas Business
Further Growth of Overseas Business Accelerate growth in Europe and U.S. business, and full-scale expansion of new drug business in China China Business Growth Image to be launched by FY2030 Shift to Ensitrelvir China new drug business scheduled to launch in FY2026 Naldemedine Olorofim Business Rapi
Slide 25: Toward the Realization of the 2030 Vision
Toward the Realization of the 2030 Vision 25
Slide 26: HIV Business: Progress in ViiV's HIV Franchise
HIV Business: Progress in ViiV's HIV Franchise (GSK's Q2 results as of July 30, 2025) Driving overall growth of the HIV business through expansion of LAI formulations and oral two-drug regimens ViiV’s sales trends*1 YoY increase from the same period 4,000 Treatment Cabenuva (cabotegravir + rilpiviri
Slide 27: Various Clinical Data Supporting the Growth of LAI Products
Various Clinical Data Supporting the Growth of LAI Products Multiple reports suggest that cabotegravir formulations are preferred for treatment and prevention Treatment VOLITION trial*1,2 Prevention CLARITY trial*3,4 A study investigating whether treatment-naïve people Phase1 study comparing accepta
Slide 28: Clinical Evidence for Oral Two-Drug Regimens Uptake
Clinical Evidence for Oral Two-Drug Regimens Uptake Dovato as a promising option not only for its viral suppression effects but also for its impact on weight PASO DOBLE trial*1,2 A head-to-head study comparing the two-drug regimen Results Dovato with Biktarvy (three-drug regimen) Achieved primary an
Slide 29: Investment Strategy for Future Growth
Investment Strategy for Future Growth Aiming to expand business in growth areas through aggressive investment, leveraging abundant cash flow Business Investment Capital Investment R&D Investment Proactive Promotion of Deals Establishing a production Enhancing in-house drug system resilient to change
Slide 30: Reintegration of Shionogi Pharma
Reintegration of Shionogi Pharma*1 As a company striving to tackle infectious diseases, we have reaffirmed the importance of building a production system resilient to environmental changes - Factors behind the reintegration - - Future Challenges and Countermeasures - Accelerating the construction of
Slide 31: Strengthening the Global Supply Chain
Strengthening the Global Supply Chain Establish manufacturing methods with superior quality and efficiency at in-house factories, and stably supply products globally under any circumstances - Developing a self-led production network - - Key initiatives toward achieving our goals - Centering on in-ho
Slide 32: Major Development Projects: Infectious Diseases
Major Development Projects: Infectious Diseases Project Indication Current stage*1 Update Acceptance of New Drug Application COVID-19 treatment Submission by the EMA*2 COVID-19 treatment Ensitrelvir Submission (age 6-11) Acceptance of New Drug Application COVID-19 PEP Submission by the FDA*3 and EMA
Slide 33: Major Development Projects: QOL Diseases with High Social Impact
Major Development Projects: QOL Diseases with High Social Impact Project Indication Current stage*1 Update Zuranolone Depression Submission Resiniferatoxin Pain associated with knee osteoarthritis Phase 3 Fragile X syndrome Phase 2/3 LPO*2 achieved Zatolmilast Jordan syndrome Phase 2 Dystrophic epid
Slide 34: S-892216 (COVID-19 Treatment, Oral): Phase 2 Trial Results
S-892216 (COVID-19 Treatment, Oral): Phase 2 Trial Results The Phase 2 trial conducted in Japan and US successfully achieved its primary endpoint Trial design Preliminary trial results Multicenter, Randomized, Double-blind, Placebo- Trial Design • Achieved primary endpoint controlled, Parallel-group
Slide 35: Cefiderocol Development Progress
Cefiderocol Development Progress Positive results confirmed in clinical trials on pediatric and neonates, application to be filed in Europe and the US within the fiscal year Trial overview Results 100 PEDI-CEFI Pediatric*1: PEDI-CEFI*2, APEKS-PEDI*3 Geometric mean plasma concentration 幾何平均血漿中濃度（ug/m
Slide 36: S-531011 Mechanism and Future Schedule
S-531011 Mechanism and Future Schedule Phase 1b trials showed positive results, and Phase 2 trials are currently underway Concept and Mechanism Phase 1b trial results*5 and future schedule • 1995: Discovery of the existence of Treg*1 • Both monotherapy and combination therapy with • 2014: Collaborat
Slide 37: Shareholder Return
Shareholder Return ® SHIONOGI
Slide 38: Shareholder Return
Shareholder Return Shareholder return policy through which shareholders can feel our growth • Considering flexible share buybacks based on the progress of growth investments • Planning the 14th consecutive annual dividend increase for FY2025 80 • End of 2nd quarter dividend: 33*1 yen 66 yen （Planned
Slide 39: Appendix
Appendix 39 @® snionoai
Slide 40: Shareholder Returns
Shareholder Returns Financial KPIs for the Medium-Term Management Plan STS2030 Revision Phase 2*1 Shareholder FY2023 FY2024 FY2025 returns Results Results Target EPS 181.17 yen 200.36 yen 200 yen or more DOE 4.0 % 4.0 % 4% ROE 13.9 % 13.1 % 14 % or more 40 *1 Materials from the STS2030 Revision Medi
Slide 41: FY2025 Exchange Rate
FY2025 Exchange Rate Exchange rate (average during the period) FY2025 Forecast Forecast Apr.-Sep. Results （5/13） （10/27） USD($) – JPY(¥) 147 yen 146 yen 146.03 yen GBP(£) – JPY(¥) 187 yen 197 yen 195.96 yen EUR(€) – JPY(¥) 153 yen 171 yen 168.06 yen 41
Slide 42: Major Development Products
Major Development Products - Infection Diseases - - QOL Diseases - Target Launch Target Launch Pipeline Indication Current stage Timing*1 Pipeline Indication Current stage Timing*1 COVID-19 treatment Submission - FY2027 Zuranolone Depression Submission FY2025 Pain associated with Resiniferatoxin Pha
Slide 43: R&D Milestones Planned for FY2025
R&D Milestones Planned for FY2025 Red: Update from July 29, 2025, to October 28, 2025, : Milestone-completed items ※Topline results: It is the timing of acquisition, and the timing of disclosure will be considered separately Disease area Pipeline Indication Current stage FY2025 1H FY2025 2H COVID-19
Slide 44: Pipeline: Infectious Diseases
Pipeline: Infectious Diseases as of October 27, 2025 Preclinical Phase 1 Phase 2 Phase 3 Submission 2025年1月31日現在 S-567123 S-743229 S-337395 Cefiderocol Olorofim Ensitrelvir COVID-19 AMR (Complicated urinary Gram-negative bacterial RSV infections Invasive Aspergillosis COVID-19 treatment Universal va
Slide 45: Pipeline: QOL Diseases with High Social Impact
Pipeline: QOL Diseases with High Social Impact as of October 27, 2025 Preclinical Phase 1 Phase 2 Phase 3 Submission Resiniferatoxin S-540956 S-151128 S-309309 Redasemtide [GRT7039] Tapinarof Zuranolone Nucleic acid adjuvan Chronic pain Obesity Acute ischemic stroke Pain associated with knee Atopic
Slide 46: Zuranolone: New Drug Application (NDA) in Japan for Major Depressive Disorder
Zuranolone: New Drug Application (NDA) in Japan for Major Depressive Disorder Based on favorable clinical trial results, submitted NDA in Japan* Primary endpoint: Change from baseline in the total HAM-D17 score*2 on Day 15 Response rate: The percentage of patients whose total HAM-D score*2 improved
Slide 47: Zuranolone: Phase 3 Validation Study Design
Zuranolone: Phase 3 Validation Study Design Subject Patients with moderate to severe major depressive disorder [Part A] Examination of superiority of Zuranolone over placebo Purpose [Part B] Examination of safety and tolerability of re-administration when necessary Primary Change from baseline in th
Slide 48: S-337395: Upcoming Development Plan (Phase 2b trial overview and design)
S-337395*1: Upcoming Development Plan (Phase 2b trial overview and design) Initiated a Phase 2b study targeting high-risk patients, aiming to develop the world’s first oral therapeutic Primary Endpoint Change from baseline in viral RNA load (qRT-PCR) Secondary Efficacy assessment: time-course change
Slide 49: Anti-HIV Drug Released by ViiV
Anti-HIV Drug Released by ViiV Product CY2024 Formulations Compounds Administrations Frequency Indications name Sales Cabenuva CAB＋RPV IM injection Q2M (LA) Treatment ￡1,013M LAI formulations Apretude CAB IM injection Q2M (LA) PrEP ￡279M Dovato DTG＋3TC Oral Every day Treatment ￡2,239M Oral two-drug
Slide 50: Growth Outlook for the HIV Market (Treatment + Prevention)
Existing 新製品・ businesses Growth Outlook for the HIV Market (Treatment + Prevention) 新規事業 In the treatment and PrEP*1 market, LA formulations will continue to drive growth Treatment Outlook for the HIV Market*2 (Treatment + PrEP) • In the US, new infections have increased by approximately 2.5-3% in r
Slide 51: Other Major Progress
Other Major Progress*1 • August − Shionogi & Co., Ltd. Selected for METI’s FY2024 Supplementary Budget Grant Program for Future-Oriented Co-Creation with the Global South – Feasibility Study on the Use of Digital Solutions to Promote Appropriate Use of Japan-Origin Antimicrobials and Hygiene Product
Slide 52: Forward-Looking Statements
Forward-Looking Statements • Forecast or target figures in this material are neither official forecasts of earnings and dividends nor guarantee of target, achievement and forecasts, but present the midterm strategies, goals and visions. Official earnings guidance should be referred to in the disclos